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A Phase I Study of DLYE5953A in Patients with Advanced or Persistent Solid Tumors

Full Title

A Phase 1, Open-label Study Evaluating the Safety and Tolerability of Escalating Doses of DLYE5953A in Patients with Refractory Solid Tumors

Purpose

The purpose of this study is to assess the safety of the investigational drug DLYE5953A at different dose levels in patients with advanced solid tumors that have continued to grow despite at least one prior regimen of therapy. DLYE5953A is a combination of an antibody and an anticancer drug. The antibody targets a protein on some cancer cells called Ly6E. It is designed to bind to cancer cells containing this protein and then release the anticancer drug, which kills the cancer cell.

Laboratory studies have shown that DLYE5953A can kill cancer cells, slow the growth of cancers, and shrink tumors. DLYE5953A is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have advanced breast, non-small cell lung, gastric, head and neck, ovarian, or pancreatic cancer which has continued to grow despite at least one prior regimen of therapy.

At least 4 weeks must pass between completion of previous therapy and entry into the study.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Shanu Modi at 646-888-5243.